MATERIAL SAFETY DATA SHEET (According to regulation (EC) 1907/2006 and amendments) Product name: Testosterone free RIA Catalog #: DE4369

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1 1. INFORMATION OF THE SUBSTANCE/PREPARATION AND COMPANY 1.1 Product name Testosterone free RIA Catalog # DE4369 Kit components Anti-Testosterone Coated tubes Testosterone-125I Calibrator 0 Calibrators 1 to 6 Controls 1 and 2 Washing Solution 1.2 Intended Use In vitro diagnostic use 1.3 Company Demeditec Diagnostics GmbH Lise-Meitner-Str Kiel Germany Tel. +49 (0) 431 / info@demeditec.de 1.4 In emergencies Call your local emergency center 2. HAZARDS IDENTIFICATION 2.1 Classification of the substance or mixture: Classification according to Regulation (EC) no 1272/2008 (CLP) Testosterone- 125 I, Calibrators and Controls Aquatic acute cat. 1 Aquatic chronic cat Classification according to Directive 1999/45/EC Testosterone- 125 I, Calibrators and Controls Dangerous for the environment Additional Information Classification according to radioprotection regulations. Testosterone- 125 I Contains radioactive material 2.2 Label elements: Labeling according to Regulation (EC) no 1272/2008 (CLP) No label required Labeling according to radioprotection regulations Testosterone- 125 I 2.3 Other hazards: Testosterone- 125 I Calibrators Controls Contains material from rabbits Tracer: <185 kbq Contains material from human origin Contains material from human origin Although these human materials have been tested for HBsAg, anti-hcv and anti-hiv-1/2 and have been found not reactive, they should be considered as potentially infectious. Page 1/6

2 3. COMPOSITION/INFORMATION ON INGREDIENTS Hazardous ingredients: Component Classification concentration Testosterone- 125 I, Calibrators and Controls containing: Sodium azide CAS-No Aquatic Acute 1- Aquatic chronic 4, < 0.1% EC-No H413 Index-No T+, N; R28, R FIRST AID MEASURES 4.1 Description of first aid measures After skin contact: - Wash immediately with soap and plenty of water for at least 10 minutes. - Consult a physician in case of inflammation. - In the case of a wound or cut rinse with plenty of water, then dress the wound. - Remove contaminated clothing After eye contact: - Wash immediately with plenty of water for at least 15 minutes. - Consult immediately a physician After ingestion: - Let drink a lot of water. - Consult immediately a physician if ingested in large quantities or if any complaints After inhalation: - Transfer the person to an open place. - If he does not breathe, proceed to artificial respiration or provide oxygen. - Consult a physician. 4.3 Indication of any immediate medical attention and special treatment needed. 5. FIRE FIGHTING MEASURES Suitable extinguishing media: Unsuitable extinguishing media: Special exposure hazards: Instructions: Special protective equipment for firefighters: - Powder, water, carbon dioxide, dry sand - - No generation of hazardous or toxic gases in dangerous quantities - Due to small quantities: no special instructions apply - Wear a breathing apparatus and protective clothing to avoid all contact with the skin and eyes. 6. ACCIDENTAL RELEASE MEASURES Personal protection: see 8 Environmental precautions: - Prevent soil and water pollution - Discharge according to local regulations Clean-up: - The radioactive material should be wiped up immediately. - Take up liquid spill into absorbent material - Discharge of absorbed material according to local regulations - Clean contaminated surfaces with water - Wash clothing according to radioprotection rules Page 2/6

3 7. HANDLING AND STORAGE Handling: - Handle radioactive material according to radioprotection rules - Observe normal hygiene standards - Discharge according to local regulations - Remove and clean contaminated clothing - Handle and open the container with care Storage: - Keep container tightly closed - Meet the legal requirements - Keep away from: heat sources, combustible materials, acids, metals - Storage temperature: see component label Specific purposes: - NA 8. EXPOSURE CONTROLS/PERSONAL PROTECTION 8.1 Control parameters Components with workplace control parameters Component No. Value mg/m 3 Sodium azide CAS TLV-TWA - TLV-STEL - TLV-Ceiling 0.29 OES-LTEL - OES-STEL 0.3 MAK 0.2 TRK MAC-TGG 8h MAC-TGG 15min MAC-Ceiling 0.3 VMA 8h - VMA 15min 0.3 GWBB 8h - GWBB 15min - Momentary value 0.29 EC 0.1 EC-STEL Exposure Controls Appropriate engineering controls Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday Personal protection equipment Respiratory Protection - Insufficient ventilation: wear respiratory protection Hand Protection - Gloves Eye Protection - Safety goggles ( 125 I-Testosterone) - Face shields Skin Protection - Protective Clothing Operators handling radioactive material should be monitored according to local regulations regarding occupational medicine. Page 3/6

4 9. PHYSICAL AND CHEMICAL PROPERTIES 9.1 Information on basic physical and chemical properties I 125 Half-life: Specific activity: 59.9 days µcie/mgr. Coated Tubes: Calibrators 0 to 6: Controls 1 and 2: Washing Solution: Testosterone- 125 I: Tubes ready to use ready to use Liquid Liquid 9.2 Other Information 10. STABILITY AND REACTIVITY Stability: All components are stable until expiry date if stored in specified conditions (see label) Reactivity/Hazardous decomposition products: No hazardous decomposition products are formed in high quantities Conditions/Materials to avoid: Keep away from metals and acids (Azide containing components) 11. TOXICOLOGICAL INFORMATION 11.1 Information on toxicological effects I 125 labeled component(s): Chronic and acute effects Radioactivity related adverse effects are only observed at exposure levels that are very much higher than those experienced with the reagents in this kit. Sodium azide: Acute oral toxicity LD50 rat: 27 mg/kg (RTECS) Absorption symptoms: Irritations of mucous membranes in the mouth, pharynx, oesophagus and gastrointestinal tract. Acute inhalation toxicity Symptoms: Irritation symptoms in the respiratory tract., Inhalation may lead to the formation of oedemas in the respiratory tract., Symptoms may be delayed. Acute dermal toxicity LD50 rabbit: 20 mg/kg (RTECS) (Regulation (EC) No 1272/2008, Annex VI) Skin irritation Possible damages: slight irritation Eye irritation Possible damages: slight irritation Sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Teratogenicity Specific target organ toxicity - single exposure Specific target organ toxicity - repeated exposure Aspiration hazard Page 4/6

5 12. ECOLOGICAL INFORMATION 12.1 Toxicity Aquatic toxicity Sodium azide: 12.2 Persistence and degradability LC50 Lepomis macrochirus (Bluegill sunfish): 0.7 mg/l; 96 h (ECOTOX Database) EC50 Daphnia pulex (Water flea): 4.2 mg/l; 48 h (ECOTOX Database) IC50 mixed culture of green algae: 272 mg/l(lit.) EC50 Photobacterium phosphoreum: 38.5 mg/l(lit.) 12.3 Bioaccumulative potential Sodium azide: Partition coefficient: n-octanol/water:log Pow: 0.3 OECD Test Guideline 117 Bioaccumulation is not expected Mobility in soil 12.5 Results of PBT and vpvb assessment 12.6 Other adverse effects Sodium azide: Forms toxic mixtures in water, dilution measures notwithstanding. Herbicide Nematocidal effect Discharge into the environment must be avoided. 13. DISPOSAL CONSIDERATIONS Provisions relating to waste: Hazardous waste (91/689/EEC). Follow local regulations for radioactive waste. Packaging/container: Waste material code packaging (91/689/EEC, Council Decision 2001/118/EC, O.J. L47 of 16/2/2001): (packaging containing residues of or contaminated by dangerous substances) Disposal methods: - Radioactive material should be disposed of following local regulations regarding radioactive waste. - Patient samples, 125 I-Testosterone, Calibrators 0 to 6 and Controls 1 and 2 are potentially infectious. They should be disposed of following established safety procedures and local regulations. - All the kit components must be considered as hazardous waste. They should be disposed of following local regulations. - Sodium azide reacts with lead and copper plumbing forming highly explosive metal azides. 14. TRANSPORT INFORMATION Radioactive material, N.O.S., UN except package Land transport Sea transport Air transport AIEA/ADR/RID regulation (Class 7, fiche 1 - ADR) IMDG regulation OACI/IATA regulation Page 5/6

6 15. REGULATORY INFORMATION This safety datasheet complies with the requirements of Regulation (EC) No. 1907/ Safety, health and environmental regulations/legislation specific for the mixture no data available 15.2 Chemical Safety assessment no data available 16. OTHER INFORMATION 16.1 Indication of changes v1: SDS changes as required by current REACH regulation (as amended by 453/2010). Classification and labeling according to CLP added Abbreviations and acronyms T+ Very toxic N Dangerous for the environment 16.3 Key literature references and sources for data SDS sheets provided by suppliers of raw materials Classification and procedure used to derive the classification for mixtures according to regulation EC 1272/2008 CLP Classification of mixtures is based on the calculation method Relevant R-phrases and/or H-P statements R28 Very toxic if swallowed R50 Very toxic to aquatic organisms R53 May cause long term adverse effects in the aquatic environment H413 May cause long lasting harmful effects to aquatic life P273 Avoid release to the environment P391 Collect spillage P501 Dispose of contents/container to 16.7 Training advice This product is designed for use by professionals Further information NOTE: The safety analysis of the lyophilized components in this kit has been performed on the reconstituted components. Therefore, the information in this MSDS and product labeling relates to the components as they will be used, i.e. after reconstitution. The human blood components included in this kit have been tested by European approved and/or FDA approved methods and found negative for HBsAg, anti-hcv and anti- HIV-1 and 2. No known method can offer complete assurance that human blood derivatives will not transmit hepatitis, AIDS or other infections. Therefore, handling of reagents, serum or plasma specimens should be in accordance with local safety procedures. All animal products and derivatives have been collected from healthy animals. Bovine components originate from countries where BSE has not been reported. This MSDS assumes that radioprotection principles and applicable regulations are known by the user. The information provided on this MSDS is correct to the best of our knowledge, information and belief at the date of its publication. The information given is designed only as guidance for safe handling, use, processing, storage, transportation, disposal and release and is not to be considered as a warranty or quality specification. The information relates only to the specific material designated and may not be valid for such material used in combination with any other material or in any process, unless specified in the text. It remains the user s own responsibility to make sure that the information is appropriate and complete for his specific use of this product. The user is also responsible for observing any laws and applicable guidelines. MSDS established : Revision number : 3 Page 6/6